Catalog Number

-

Brand Name

Midas Rex MR8

Version/Model Number

IRD800

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K183515,K183515

Product Code

GBX

Product Code Name

CATHETER, IRRIGATION

Public Device Record Key

9f038b69-6d68-4d28-84d3-63221b240b10

Public Version Date

June 17, 2019

Public Version Number

1

DI Record Publish Date

June 07, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-